(87 days)
Not Found
No
The document describes passive electrodes for defibrillation and pacing, with no mention of AI/ML or related concepts.
No
The device, SVL-9630 electrodes, is a component used with therapeutic devices (defibrillators and pacemakers) but does not itself provide therapy. It acts as a conductive interface.
No
Explanation: The electrodes are used to monitor, defibrillate, or pace the patient, providing a conductive interface for devices like AEDs or pacemakers, rather than diagnosing a condition themselves.
No
The device description explicitly states the device consists of "a pair of non sterile, hydrogel polymeric selfadhesive electrode pads," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are used in conjunction with external defibrillators and pacemakers to monitor, defibrillate, or pace the adult patient. This involves direct interaction with the patient's body for therapeutic and monitoring purposes.
- Device Description: The description details the physical components of the electrodes and their function as a conductive interface with the patient's skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for direct patient care.
N/A
Intended Use / Indications for Use
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
SurVivaLink
Amendment 1
P.05/06
DEC I 0 1999
510(k) Summary
ADMINSTRATIVE INFORMATION H-1.
H-1.1 Name and address
Survivalink Corporation Submitted by: 5430 Feltl Road Minneapolis, MN 55343
| Contact Person: | Sew-Wah Tay, Ph.D. |
|---|---|
| Telephone No .: | 612-939-2942 |
| Facsimile No .: | 612-939-4191 |
| Email address: | stay@survivalink.com |
Date Prepared: September 8, 1999
H-1.2 Device Name
| Common or Usual Name: | Disposable Polymer (Hydrogel) Multifunctional Electrode |
|---|---|
| Device Name: | SVL-9630 |
| Trade Name: | SVL-9630 |
Classification Name H-1.3
Disposable Single Use Accessory (Electrode) to: a) Semi-automatic low energy DC defibrillator 21CFR 870.5300; Class II b) Cardiac Monitor (Cardiotachometer and Rate Alarm) 21CFR $870.2300; Class II
H-1.4 Applicant
| Applicant's Name: | Survivalink, Corporation
5430 Feltl Road
Minneapolis, MN 55343 |
| ------------------- | ---------------------------------------------------------------------- |
|---|
H-2. PREDICATE DEVICE
H-3. INDICATION FOR USE
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
1
510(k) K993072
The electrodes are intended for short-term use (